510(k) K990897 ยท CAF Nebulizer (Direct Patient Interface)
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
| Applicant | Puritan-Bennett Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Mar 15, 2000 |
| Received | Mar 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02
The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient Terminated |
CBK | None listed |
| Jan 24, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389
The intended use of the oxygen senso Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.